A Study in Non-squamous Non Small Cell Lung Cancer in Asian Patients
19 czerwca 2013 zaktualizowane przez: Eli Lilly and Company
Post-marketing Clinical Trial of Induction Chemotherapy of Pemetrexed Plus Carboplatin Followed by Pemetrexed Maintenance Therapy for Advanced Nonsquamous Non-small Cell Lung Cancer
To investigate efficacy and safety of the combination with pemetrexed plus carboplatin, followed by pemetrexed in patients with advanced nonsquamous Non Small Cell Lung Cancer (NSCLC) who receive at least one dose of the induction therapy.
Przegląd badań
Status
Status
Zakończony
Warunki
Warunki
Interwencja / Leczenie
Interwencja / Leczenie
Typ studiów
Typ studiów
Interwencyjne
Zapisy (Rzeczywisty)
Zapisy
109
Faza
Faza
- Faza 4
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Lokalizacje studiów
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Aichi, Japonia, 460-0001
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Chiba, Japonia, 277 8577
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Ehime, Japonia, 790-0007
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Fukuoka, Japonia, 812-8582
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Hokkaido, Japonia, 062-0931
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Hyogo, Japonia, 673-8558
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Kanagawa, Japonia, 236-0051
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Kumamoto, Japonia, 860-8556
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Miyagi, Japonia, 980-8574
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Niigata, Japonia, 951-8520
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Okayama, Japonia, 700-8558
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Osaka, Japonia, 589-8511
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Shizuoka, Japonia, 411-8777
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Tochigi, Japonia, 320-0834
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Tokyo, Japonia, 113-8677
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Yamaguchi, Japonia, 755-0241
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Kryteria kwalifikacji
Wiek uprawniający do nauki
20 lat i starsze (Dorosły, Starszy dorosły)
Akceptuje zdrowych ochotników
Nie
Płeć kwalifikująca się do nauki
Wszystko
Opis
Inclusion Criteria:
- Non-squamous cell Non Small Cell Lung Cancer (NSCLC) disease
- Clinical stage IIIB/IV or recurrent disease after surgery
- No prior systemic chemotherapy, immunotherapy, targeted therapy or biological therapy, including adjuvant therapy
- Prior radiation therapy is allowed to less than 25% of the bone marrow
- Measurable disease as defined by response evaluation criteria in solid tumors (RECIST)
- The Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Adequate organ function
- Estimated life expectancy of at least 12 weeks
Exclusion Criteria:
- Clinically significant third-space fluid collections
- Central nervous system disease other than stable and treated brain metastasis
- More than 3 weeks interval between the surgery and enrollment request date
- Unable to interrupt aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs), for a 5 days period
- Unable or unwilling to take folic acid or vitamin B12 supplementation
- Unable to take corticosteroids.
- Serious concomitant disorder that, in the opinion of the investigator, would compromise the patient's ability to adhere to the protocol
- Currently have and historically had interstitial pneumonitis (interstitial pneumonia) or pulmonary fibrosis manifested as opacity on Chest x-ray or Computed tomography (CT)
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Nie dotyczy
- Model interwencyjny: Zadanie dla jednej grupy
- Maskowanie: Brak (otwarta etykieta)
Liczba ramion
1
Broń i interwencje
Grupa uczestników / ArmGrupa uczestników / Arm |
Interwencja / LeczenieInterwencja / Leczenie |
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Eksperymentalny: Pemetrexed + Carboplatin
After four 21-day cycles of Pemetrexed plus Carboplatin treatment, Pemetrexed monotherapy is continued until study discontinuation.
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Induction Therapy: 500 milligrams per square meter (mg/m^2) given intravenously (IV) on Day 1 of every 21-day cycle for 4 cycles. Maintenance Therapy: 500 mg/m^2 given IV on Day 1 of every 21-day cycle until disease progression or unacceptable toxicity.
Inne nazwy:
Dosage equal to area under the curve (AUC)6 milligrams per milliliter per minute (mg/mL/min) for participant, given IV on Day 1 of every 21-day cycle for 4 cycles.
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Co mierzy badanie?
Podstawowe miary wyniku
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Progression Free Survival (PFS) During the Induction and Maintenance Therapy Periods
Ramy czasowe: Enrollment to the date of progressive disease (PD) or the date of death from any cause (up to 18 months)
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PFS defined as time from enrollment date to first date of objective progression of disease or of death from any cause.
Tumor response was assessed using Response Evaluation Criteria in Solid Tumors (RECIST) guideline version 1.0, which define when cancer participants improve ("respond"), stay the same ("stabilize"), or worsen ("progression") during treatments.
Participants receiving any subsequent systemic anticancer therapy before objective progression or death were censored at date of last objective progression-free disease assessment before starting subsequent systemic anticancer therapy.
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Enrollment to the date of progressive disease (PD) or the date of death from any cause (up to 18 months)
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Miary wyników drugorzędnych
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Overall Survival (OS) During the Induction and Maintenance Therapy Periods
Ramy czasowe: Enrollment to the date of death from any cause (up to 30.8 months)
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OS was defined as the time from the enrollment date to the date of death from any cause.
For participants who were alive, OS was censored at the last contact.
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Enrollment to the date of death from any cause (up to 30.8 months)
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Percentage of Participants Who Achieve a Complete Response (CR), Partial Response (PR), or Stable Disease (SD) During the Induction and Maintenance Therapy Periods
Ramy czasowe: Enrollment to date of progressive disease (up to 18 months)
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Calculated as the percentage of participants who achieved a confirmed CR, PR, or SD.
Tumor response was assessed using Response Evaluation Criteria in Solid Tumors (RECIST) guideline version 1.0, which define when cancer participants improve ("respond"), stay the same ("stabilize"), or worsen ("progression") during treatments.
CR = disappearance of all target lesions.
PR = 30% decrease in the sum of the longest diameter of target lesions.
Progressive Disease (PD) = 20% increase in the sum of the longest diameter of target lesions.
SD = small changes that do not meet above criteria.
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Enrollment to date of progressive disease (up to 18 months)
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Percentage of Participants Who Achieved a Complete Response (CR) or Partial Response (PR) During the Induction and Maintenance Therapy Periods
Ramy czasowe: Enrollment to date of progressive disease (up to 18 months)
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Calculated as the percentage of participants who achieved a confirmed CR or PR.
Tumor response was assessed using Response Evaluation Criteria in Solid Tumors (RECIST) guideline version 1.0, which define when cancer participants improve ("respond"), stay the same ("stabilize"), or worsen ("progression") during treatments.
CR = disappearance of all target lesions.
PR = 30% decrease in the sum of the longest diameter of target lesions.
Progressive Disease (PD) = 20% increase in the sum of the longest diameter of target lesions.
Stable Disease (SD) = small changes that do not meet above criteria.
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Enrollment to date of progressive disease (up to 18 months)
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Progression Free Survival (PFS) During the Maintenance Therapy Period
Ramy czasowe: From the start of maintenance therapy in Cycle 5 (21-day cycle) until the date of measured progressive disease (PD) or death from any cause (up to 24.4 months)
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Measured from the date of the first dose of the maintenance therapy.
Calculated by subtracting induction therapy period from PFS. Tumor response assessed using Response Evaluation Criteria in Solid Tumors (RECIST) guideline version 1.0; define when cancer participants improve ("respond"), stay the same ("stabilize"), or worsen ("progression") during treatments.
Participants receiving any subsequent systemic anticancer therapy before objective progression or death were censored at date of last objective progression-free disease assessment before starting subsequent systemic anticancer therapy.
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From the start of maintenance therapy in Cycle 5 (21-day cycle) until the date of measured progressive disease (PD) or death from any cause (up to 24.4 months)
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Overall Survival (OS) During the Maintenance Therapy Period
Ramy czasowe: From the start of maintenance therapy in Cycle 5 (21-day cycle) until the date of measured progressive disease (PD) or death from any cause (up to 26.3 months)
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OS was defined as the duration from the date of the first dose of the maintenance therapy to the date of death from any cause and was calculated by subtracting the induction therapy period from OS. Participants receiving any subsequent systemic anticancer therapy before objective progression or death were censored at date of last objective progression-free disease assessment before starting subsequent systemic anticancer therapy.
For participants who were alive, OS was censored at the last contact.
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From the start of maintenance therapy in Cycle 5 (21-day cycle) until the date of measured progressive disease (PD) or death from any cause (up to 26.3 months)
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Percentage of Participants Who Achieved a Complete Response (CR), Partial Response (PR), or Stable Disease (SD) During the Maintenance Therapy Period
Ramy czasowe: From the start of maintenance therapy in Cycle 5 (21-day cycle) until the date of measured progressive disease (PD) or death from any cause (up to 18 months)
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Percentage of participants who achieved confirmed CR (disappearance of all target lesions), PR (30% decrease in sum of longest diameter of target lesions), or SD (small changes that do not meet above criteria).
Response derived from target lesion assessments performed before maintenance therapy (as baseline), during maintenance therapy (as post-baseline), and non-target lesion assessments performed during maintenance therapy according to RECIST guideline version 1.0, defines when cancer participants improve ("respond"), stay the same ("stabilize"), or worsen ("progression") during treatments.
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From the start of maintenance therapy in Cycle 5 (21-day cycle) until the date of measured progressive disease (PD) or death from any cause (up to 18 months)
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Percentage of Participants Who Observe a Complete Response (CR), Partial Response (PR), or Stable Disease (SD) During the Induction Therapy Period
Ramy czasowe: Enrollment to the date of PD, or end of induction period up to Cycle 4 (21-day cycle)
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Calculated as the percentage of participants who achieved a CR, PR, or SD (confirmed or not).
Tumor response was assessed using Response Evaluation Criteria in Solid Tumors (RECIST) guideline version 1.0, which define when cancer participants improve ("respond"), stay the same ("stabilize"), or worsen ("progression") during treatments.
CR = disappearance of all target lesions.
PR = 30% decrease in the sum of the longest diameter of target lesions.
Progressive Disease (PD) = 20% increase in the sum of the longest diameter of target lesions.
SD = small changes that do not meet above criteria.
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Enrollment to the date of PD, or end of induction period up to Cycle 4 (21-day cycle)
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Percentage of Participants Who Achieve a Complete Response (CR) or a Partial Response (PR) During the Induction Therapy Period
Ramy czasowe: Enrollment to date of PD, or end of induction period up to Cycle 4 (21-day cycle)
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Calculated as percentage of participants who achieved a CR or PR (confirmed or not).
Tumor response was assessed using Response Evaluation Criteria in Solid Tumors (RECIST) guideline version 1.0, which define when cancer participants improve ("respond"), stay the same ("stabilize"), or worsen ("progression") during treatments.
CR = disappearance of all target lesions.
PR = 30% decrease in sum of the longest diameter of target lesions.
Progressive Disease (PD) = 20% increase in the sum of longest diameter of target lesions.
Stable Disease (SD) = small changes that do not meet above criteria.
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Enrollment to date of PD, or end of induction period up to Cycle 4 (21-day cycle)
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Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Sponsor
Sponsor
Publikacje i pomocne linki
Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów
Rozpoczęcie studiów
1 listopada 2009
Zakończenie podstawowe (Rzeczywisty)
Zakończenie podstawowe
1 marca 2011
Ukończenie studiów (Rzeczywisty)
Ukończenie studiów
1 czerwca 2012
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany
24 listopada 2009
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy przesłany, który spełnia kryteria kontroli jakości
24 listopada 2009
Pierwszy wysłany (Oszacować)
Pierwszy wysłany
26 listopada 2009
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Oszacować)
Ostatnia wysłana aktualizacja
27 sierpnia 2013
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
19 czerwca 2013
Ostatnia weryfikacja
Ostatnia weryfikacja
1 czerwca 2013
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
- Choroby Układu Oddechowego
- Nowotwory
- Choroby płuc
- Nowotwory według lokalizacji
- Nowotwory Układu Oddechowego
- Nowotwory klatki piersiowej
- Rak, Bronchogenny
- Nowotwory oskrzeli
- Nowotwory płuc
- Rak, płuco niedrobnokomórkowe
- Molekularne mechanizmy działania farmakologicznego
- Inhibitory syntezy kwasów nukleinowych
- Inhibitory enzymów
- Środki przeciwnowotworowe
- Antagoniści kwasu foliowego
- Karboplatyna
- Pemetreksed
Inne numery identyfikacyjne badania
Inne numery identyfikacyjne badania
- 12628
- H3E-JE-JMII (Inny identyfikator: Eli Lilly and Company)
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .